Z-0334-2022 Class II Terminated
FDA device recall Z-0334-2022 was initiated by Orchestrate Orthodontic Technologies, Inc. on November 11, 2021 and is designated Class II. Reason for recall: Due to product label/labeling being altered from it's approved state. The recall status is terminated (terminated January 10, 2024). Affected quantity: 127 copies.
Recall Details
- Product Type
- Devices
- Report Date
- December 15, 2021
- Initiation Date
- November 11, 2021
- Termination Date
- January 10, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 127 copies
Product Description
O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth movement) MKT-LB-002 Rev 1 for Orchestrate3d Software v.3.1 - v5.0.4
Reason for Recall
Due to product label/labeling being altered from it's approved state.
Distribution Pattern
Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI. The countries of Argentina, Australia, Bolivia, Brazil, Canada, Costa Rica, India, Ireland, Mongolia, New Zealand, Pakistan, Spain and Thailand.
Code Information
All versions (lots) of the software are affected. User Manual MKT-LB-002 Rev 1